Clearance Summary
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER received FDA 510(k) clearance under submission number K060440, sponsored by Codonics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-03-16.
- Submission: K060440
- Applicant / Sponsor: Codonics, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 2006-03-16
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.